ID

39129

Description

DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C); ODM derived from: https://clinicaltrials.gov/show/NCT01743521

Link

https://clinicaltrials.gov/show/NCT01743521

Keywords

Versions (2)
  1. 12/3/19 12/3/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 3, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Early Chronic Hepatitis C NCT01743521

English

Eligibility Early Chronic Hepatitis C NCT01743521

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written, informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. hcv genotype 1 infection
Description

Hepatitis C virus genotype 1 Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3532919
UMLS CUI [1,2]
C3714514
3. quantifiable hcv rna at screening and baseline (>10,000 iu/ml)
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
4. recent hepatitis c infection with an estimated duration of infection >6 months and ≤
Description

Hepatitis C Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0449238
18 months defined as a) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) documented anti-hcv antibody negative or hcv rna negative within the 24 months prior to anti-hcv antibody positive result or b) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the 12 months prior to first positive hcv antibody or hcv rna with no other cause of acute hepatitis identifiable
Description

Hepatitis C Antibodies | Hepatitis C RNA positive | Hepatitis C antibody negative | Hepatitis C RNA negative | Hepatitis | Jaundice | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0166049
UMLS CUI [2]
C0855842
UMLS CUI [3]
C0853904
UMLS CUI [4]
C0855841
UMLS CUI [5]
C0019158
UMLS CUI [6]
C2010848
UMLS CUI [7]
C0151905
5. compensated liver disease (child-pugh a)
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
6. negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
7. if heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after rbv therapy has ended. note: hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. as of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
Description

Childbearing Potential Sexually active Contraceptive methods Quantity | Gender Without Vasectomy | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Contraceptive methods Except Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0042387
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C2985296
8. subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
Description

Patient's condition stable Physical Examination | Patient's condition stable Medical History | Patient's condition stable Vital signs

Data type

boolean

Alias
UMLS CUI [1,1]
C1282982
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1282982
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1282982
UMLS CUI [3,2]
C0518766
9. adequate english to provide written, informed consent and to provide reliable responses to the study interview
Description

Language skills English | Informed Consent | Patient interview

Data type

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0683518
additional inclusion criteria for hiv positive individuals
Description

Inclusion criteria Patients HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0019699
confirmed hiv infection > 6 months duration
Description

HIV Infection Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0449238
cd4 > 200 cells/mm3 and hiv < 50 c/ml on stable art at least 3 months prior to treatment
Description

CD4 Count determination | HIV viral load | Antiretroviral therapy Stable

Data type

boolean

Alias
UMLS CUI [1]
C0243009
UMLS CUI [2]
C1168369
UMLS CUI [3,1]
C1963724
UMLS CUI [3,2]
C0205360
or
Description

ID.14

Data type

boolean

cd4 >= 500 cells/mm3 and hiv vl < 100,000 not on art
Description

CD4 Count determination | HIV viral load | Antiretroviral therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0243009
UMLS CUI [2]
C1168369
UMLS CUI [3,1]
C1963724
UMLS CUI [3,2]
C0332197
if on art must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( tdf), lamivudine ( 3tc), emtricitabine (ftc), efavirenz (efv), abacavir (abc), raltegravir (ral), etravirine (etv), rilpivirine (ril), ritonavir boosted atazanavir (r/atz) * combination must be supported by current hiv treatment guidelines
Description

Antiretroviral therapy | Combined Modality Therapy | Tenofovir | Lamivudine | emtricitabine | efavirenz | abacavir | raltegravir | etravirine | Rilpivirine | Atazanavir+Ritonavir

Data type

boolean

Alias
UMLS CUI [1]
C1963724
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0384228
UMLS CUI [4]
C0209738
UMLS CUI [5]
C0909839
UMLS CUI [6]
C0674428
UMLS CUI [7]
C0663655
UMLS CUI [8]
C1871526
UMLS CUI [9]
C1456409
UMLS CUI [10]
C1566826
UMLS CUI [11]
C1977391
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
Description

Study Subject Participation Status | Follow-up Unlikely | Collection of blood specimen Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0750558
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C0558080
current injecting drug use (any injecting within previous 4 weeks)
Description

Injecting drug user

Data type

boolean

Alias
UMLS CUI [1]
C0556025
standard exclusions to peg-interferon (peg-ifn), ribavirin (rbv) and telaprevir (tpv) therapy
Description

PEGINTERFERON | Ribavirin | telaprevir

Data type

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2]
C0035525
UMLS CUI [3]
C1876229
Back to the top of the page

Similar models

Eligibility Early Chronic Hepatitis C NCT01743521

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Hepatitis C virus genotype 1 Infection
Item
2. hcv genotype 1 infection
boolean
C3532919 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
3. quantifiable hcv rna at screening and baseline (>10,000 iu/ml)
boolean
C1272251 (UMLS CUI [1])
Hepatitis C Duration
Item
4. recent hepatitis c infection with an estimated duration of infection >6 months and ≤
boolean
C0019196 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis C Antibodies | Hepatitis C RNA positive | Hepatitis C antibody negative | Hepatitis C RNA negative | Hepatitis | Jaundice | Alanine aminotransferase increased
Item
18 months defined as a) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) documented anti-hcv antibody negative or hcv rna negative within the 24 months prior to anti-hcv antibody positive result or b) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the 12 months prior to first positive hcv antibody or hcv rna with no other cause of acute hepatitis identifiable
boolean
C0166049 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
C0853904 (UMLS CUI [3])
C0855841 (UMLS CUI [4])
C0019158 (UMLS CUI [5])
C2010848 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
Compensated liver disease Child-Pugh Classification
Item
5. compensated liver disease (child-pugh a)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Pregnancy test negative
Item
6. negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
boolean
C0427780 (UMLS CUI [1])
Childbearing Potential Sexually active Contraceptive methods Quantity | Gender Without Vasectomy | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Contraceptive methods Except Hormonal contraception
Item
7. if heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after rbv therapy has ended. note: hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. as of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0042387 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0700589 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C2985296 (UMLS CUI [5,3])
Patient's condition stable Physical Examination | Patient's condition stable Medical History | Patient's condition stable Vital signs
Item
8. subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
boolean
C1282982 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1282982 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1282982 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
Language skills English | Informed Consent | Patient interview
Item
9. adequate english to provide written, informed consent and to provide reliable responses to the study interview
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0683518 (UMLS CUI [3])
Inclusion criteria Patients HIV Seropositivity
Item
additional inclusion criteria for hiv positive individuals
boolean
C1512693 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
HIV Infection Duration
Item
confirmed hiv infection > 6 months duration
boolean
C0019693 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
CD4 Count determination | HIV viral load | Antiretroviral therapy Stable
Item
cd4 > 200 cells/mm3 and hiv < 50 c/ml on stable art at least 3 months prior to treatment
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
ID.14
Item
or
boolean
CD4 Count determination | HIV viral load | Antiretroviral therapy Absent
Item
cd4 >= 500 cells/mm3 and hiv vl < 100,000 not on art
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Antiretroviral therapy | Combined Modality Therapy | Tenofovir | Lamivudine | emtricitabine | efavirenz | abacavir | raltegravir | etravirine | Rilpivirine | Atazanavir+Ritonavir
Item
if on art must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( tdf), lamivudine ( 3tc), emtricitabine (ftc), efavirenz (efv), abacavir (abc), raltegravir (ral), etravirine (etv), rilpivirine (ril), ritonavir boosted atazanavir (r/atz) * combination must be supported by current hiv treatment guidelines
boolean
C1963724 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0384228 (UMLS CUI [3])
C0209738 (UMLS CUI [4])
C0909839 (UMLS CUI [5])
C0674428 (UMLS CUI [6])
C0663655 (UMLS CUI [7])
C1871526 (UMLS CUI [8])
C1456409 (UMLS CUI [9])
C1566826 (UMLS CUI [10])
C1977391 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Follow-up Unlikely | Collection of blood specimen Unwilling
Item
individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
boolean
C2348568 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Injecting drug user
Item
current injecting drug use (any injecting within previous 4 weeks)
boolean
C0556025 (UMLS CUI [1])
PEGINTERFERON | Ribavirin | telaprevir
Item
standard exclusions to peg-interferon (peg-ifn), ribavirin (rbv) and telaprevir (tpv) therapy
boolean
C0982327 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C1876229 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial